Predicting the Safety and Effectiveness of Inferior Vena Cava Filters

NCT ID: NCT02381509

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1428 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2021-09-20

Brief Summary

PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from 6 manufacturers placed in subjects for the prevention of pulmonary embolism (PE). This study will enroll up to 1,800 IVC filter subjects (with a maximum of 300 subjects per IVC filter brand) at up to 60 sites in the US. The primary objective of this investigational device exemption (IDE) clinical investigation is to evaluate the safety and effectiveness of the commercially available IVC filters (retrievable and permanent) in subjects with clinical need for mechanical prophylaxis of PE with an IVC filter.

Detailed Description

The overall goal is to characterize the current practice of IVC filter placement, including the indications, filter type, frequency and success of filter removal, safety of placement initially and in the long term, including filter mechanical stability and caval patency, and the frequency of subsequent episodes of PE and recurrence of DVT. The first steps are to identify the characteristics of use in a broad range of clinical practice settings in the US.

Commercially available IVC filters from 6 manufacturers in the United States will be used. The type of FDA-cleared IVC filter implanted will be left to the discretion of the Principal Investigator at the Site. The following IVC filters will be utilized in this trial:

1. ALN Vena Cava Filter (with and without hook) (ALN Implants Chirurgicaux)

2. Option™ Elite Retrievable Vena Cava Filter (Argon Medical Devices Inc., designed and manufactured by Rex Medical)

3. VenaTech® LP Vena Cava Filter (B Braun Interventional Systems, Inc.) and VenaTech® Convertible™ Vena Cava Filter

4. DENALI® Vena Cava Filter System (DL900F, DL900J) (Bard Peripheral Vascular, Inc.)

5. Cook Günther-Tulip™ Vena Cava Filter (Cook Incorporated)

6. Cordis OPTEASE® Retrievable Vena Cava Filter and Cordis TRAPEASE® Permanent Vena Cava Filter (Cordis Corporation)

Subjects will be evaluated at Procedure, Discharge, 3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. All subjects in whom the IVC filter is removed will be followed for 1-month postretrieval. Mandated follow-up imaging will be performed at 3 months (plain film) and 12 and 24 months (contrast abdominal CT). In addition, clinical visits with physical exam will be performed at 3 months, 12 months and 24 months.

Conditions

Pulmonary Embolism; Deep Vein Thrombosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

IVC Filter

IVC filter for the prevention of PE

IVC Filter

Intervention Type: DEVICE

Interventions

IVC Filter

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or Female, age 18 years or older;
• Requires IVC filter for prevention of pulmonary embolism (PE);
• Provide written informed consent and written HIPAA authorization prior to initiation of study procedures;
• Willing to comply with the specified follow-up

Exclusion Criteria

• Subject is unable to participate in study evaluations pre- and post-treatment
• Known sensitivity to contrast or serious contrast reaction such as anaphylaxis for which premedication is known to be unsuccessful in alleviating symptoms

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ALN Implants Chirurgicaux

UNKNOWN

Sponsor Role: collaborator

B. Braun Interventional Systems, Inc

INDUSTRY

Sponsor Role: collaborator

Bard Peripheral Vascular, Inc.

INDUSTRY

Sponsor Role: collaborator

Cook Group Incorporated

INDUSTRY

Sponsor Role: collaborator

Cordis Corporation

INDUSTRY

Sponsor Role: collaborator

Argon Medical Devices

INDUSTRY

Sponsor Role: collaborator

Society of Interventional Radiology Foundation

OTHER

Sponsor Role: collaborator

Society for Vascular Surgery

OTHER

Sponsor Role: collaborator

Carelon Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David L. Gillespie, MD, FACS

Role: STUDY_CHAIR

Cape Cod Hospital

Matt Johnson, MD

Role: STUDY_CHAIR

Indiana University School of Medicine

Locations

University of Arkansas

Little Rock, Arkansas, United States

Ronald Regan UCLA Medical Center

Los Angeles, California, United States

Palo Alto VA

Palo Alto, California, United States

University of California San Francisco

San Francisco, California, United States

Harbor-UCLA Medical Center

Torrance, California, United States

University of Colorado

Aurora, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Medstar Georgetown

Washington D.C., District of Columbia, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

The Heart Institute Largo

Largo, Florida, United States

University of Miami Hospital and Clinics/Jackson Memorial

Miami, Florida, United States

Florida Hospital

Orlando, Florida, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Tallahasse Memorial Hospital

Tallahassee, Florida, United States

St. Mary's Medical Center

West Palm Beach, Florida, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Carle Heart & Vascular Institute

Urbana, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, United States

Boston Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Southcoast Hospital

North Dartmouth, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

St. Louis University

St Louis, Missouri, United States

Washington University

St Louis, Missouri, United States

Hackensack UMC

Hackensack, New Jersey, United States

Overlook Medical Center

Summit, New Jersey, United States

Albany Medical Center

Albany, New York, United States

Feinstein Institute

Manhasset, New York, United States

Mount Sinai Hospital

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

NY Presbyterian Weil Cornell Medical Ctr

New York, New York, United States

Rochester Regional Health System

Rochester, New York, United States

University Hospital/SUNY Upstate

Syracuse, New York, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Duke Medical Center

Durham, North Carolina, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Miami Valley Hospital/Wright State University

Dayton, Ohio, United States

Fairfield Medical Center

Lancaster, Ohio, United States

University of Oklahoma-Tulsa

Tulsa, Oklahoma, United States

Oregon Health & Science Center

Portland, Oregon, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital/Miriam Hospital

Providence, Rhode Island, United States

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

UT Southwestern

Dallas, Texas, United States

Memorial Hermann Hospital

Houston, Texas, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Medical College of WI/Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, United States

Countries

United States

References

Johnson MS, Spies JB, Scott KT, Kato BS, Mu X, Rectenwald JE, White RA, Lewandowski RJ, Khaja MS, Zuckerman DA, Casciani T, Gillespie DL. Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months. J Vasc Surg Venous Lymphat Disord. 2023 May;11(3):573-585.e6. doi: 10.1016/j.jvsv.2022.11.002. Epub 2023 Feb 23.

Reference Type: DERIVED

PMID: 36872169 (View on PubMed)

Johnson MS, Spies JB, Scott KT, Kato BS, Mu X, Rectenwald JE, White RA, Lewandowski RJ, Khaja MS, Zuckerman DA, Casciani T, Gillespie DL. Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months. J Vasc Interv Radiol. 2023 Apr;34(4):517-528.e6. doi: 10.1016/j.jvir.2022.12.009. Epub 2023 Feb 23.

Reference Type: DERIVED

PMID: 36841633 (View on PubMed)

Other Identifiers

M01482

Identifier Type: -

Identifier Source: org_study_id